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临床试验/NCT04902417
NCT04902417已完成不适用

Influence of Increased Dairy Product Consumption on Markers of Inflammation and Cardiometabolic Disease

York University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Postprandial Inflammation

研究概览

简要总结

The purpose of this study is to determine whether 6-weeks of increased dairy consumption can reduce inflammation and other markers of chronic disease while fasted or following a high-fat meal.

详细描述

Following the acquisition of informed consent, eligibility to participate in the study will be determined using questionnaires, and certain parameters determined from a finger-prick blood sample. Eligible participants will be assigned to complete two 6-week dietary interventions in random order, with at least a 4 week "wash out" period (i.e. their habitual eating) in between. The two dietary interventions are: 1) Participants normal, low-dairy diet; and 2) A higher dairy diet where 3 servings per day of dairy foods are provided. Prior to beginning either 6-week diet intervention, participants will be asked to attend the laboratory at York University after an overnight fast to undergo baseline testing.

Following baseline testing, participants will meet with a registered dietitian (RD) to discuss each diet arm. Specifically, if they are on the dairy diet, participants will receive advice on how to incorporate these dairy foods into their diet by replacing other foods of similar energy content so as to not increase their total energy intake and body weight. They will meet with the RD at several other times throughout the study. During each 6-week diet period, they will be asked to keep their physical activity levels constant and to not adopt any other major dietary changes during the study.

At the end of each 6-week intervention period, participants will be asked to return to York University to repeat the initial set of tests performed at baseline. In addition to the fasted tests, a number of tests will be performed after asking participants to consume a high-fat test meal (i.e. a fast-food breakfast). Various measurements will continue to be taken for around 6 hours after this meal is consumed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) ≥ 25 kg/m2
  • ≤ 2 structured exercise sessions/week
  • Habitual low dairy consumption (≤ 1 serving/day)
  • Having at least two other metabolic risk factors based on clinical guidelines:
  • Elevated blood pressure (≥130/≥85 mm Hg)
  • Impaired fasting glucose (≥5.6 mmol/L) measured using a finger prick sample
  • Impaired fasting triglycerides (≥1.7 mmol/L) or high-density lipoprotein (<1.03 mmol/L for males, <1.3 mmol/L for females) measured using a finger prick blood sample.
  • Increased waist circumference (≥102 cm for males and ≥88 cm for females).
  • Borderline high fasting low-density lipoprotein (≥3.5 mmol/L) or total cholesterol (≥5.2 mmol/L).

排除标准

  • Allergy to dairy foods, diagnosed lactose intolerance or an aversion to foods provided during the study
  • Previous history of diabetes and/or related cardiovascular disease
  • The use of multiple medications for managing lipids, glucose and/or blood pressure

研究组 & 干预措施

Low Dairy Habitual Diet

No Intervention

Participants will follow their usual diet for 6-weeks, which includes low dairy consumption as screened for with the inclusion criteria.

High Dairy Diet

Experimental

Participants will be provided with 3 servings of dairy per day to replace other foods within their diet (preventing weight gain over the intervention period) for 6-weeks

干预措施: Dairy Foods (Yoghurt, Cheese, Milk) (Other)

结局指标

主要结局

Postprandial Inflammation

时间窗: 5 hour post meal

Concentration of Interleukin-6

Fasting Inflammation

时间窗: immediately after the 6 week intervention

Concentration of Interleukin-6

Fasting Inflammation

时间窗: pre-intervention

Concentration of Interleukin-6

Postprandial Inflammation

时间窗: 1 hour post meal

Concentration of Interleukin-6

Postprandial Inflammation

时间窗: 2 hour post meal

Concentration of Interleukin-6

Postprandial Inflammation

时间窗: 3 hour post meal

Concentration of Interleukin-6

Postprandial Inflammation

时间窗: 4 hour post meal

Concentration of Interleukin-6

次要结局

  • Fasting insulin(immediately after the 6 week intervention)
  • vascular measures(immediately after the 6 week intervention)
  • Body composition(immediately after the 6 week intervention)
  • Fasting glucose(immediately after the 6 week intervention)
  • Fasting Lipids(immediately after the 6 week intervention)
  • Fasting Lipids(pre-intervention)
  • Fasting glucose(pre-intervention)
  • Fasting insulin(pre-intervention)
  • vascular measures(pre-intervention)
  • Body composition(pre-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Josse

Assistant Professor

York University

研究点 (1)

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